V.A.C. Granufoam Silver Protection Dressing
FDA 510(k) K050261 · Kinetic Concepts, Inc.
510(k) numberK050261
Submission
- Device name
- V.A.C. Granufoam Silver Protection Dressing
- Applicant
- Kinetic Concepts, Inc.
San Antonio, TX, US - Received
- February 4, 2005
- Decision date
- May 26, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
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| K261338 | RENASYS DYNAFLOW Kit (66807741)OMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2026SE |
| K253263 | ConvaVAC Negative Pressure Wound Therapy SystemOMP · Traditional | Convatec Limited, Gdc Building | 06/24/2026SE |
| K253199 | Curasys 2 (EMDN0003)OMP · Traditional | CG Bio Co., Ltd. | 06/23/2026SE |
| K260646 | Renasys Edge (66803126)OMP · Traditional | Smith & Nephew Medical, Ltd. | 05/27/2026SE |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500)OMP · Special | Cork Medical | 05/21/2026SE |
| K254019 | Wound Geni NPWT SystemOMP · Traditional | Bechtel Medical, Inc. | 05/04/2026SE |
| K253429 | Genadyne ASTRA NPWTOMP · Traditional | Genadyne Biotechnologies, Inc. | 03/12/2026SE |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…OMP · Traditional | Deroyal Industries, Inc. | 11/21/2025SE |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy SystemOMP · Traditional | Alleva Medical Devices | 10/03/2025SE |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyOMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2025SE |
More from Smith & Nephew Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K041642 | V.A.C. Granufoam Silver DressingOMP · Traditional | 01/25/2005SE |
| K032310 | Mini V.A.C., V.A.C. Freedom, V.A.C. AtsOMP · Traditional | 10/10/2003SE |
| K022011 | V.A.C. Abdominal DressingFTL · Traditional | 02/26/2003SE |
| K021500 | Vacuum Assisted ClosureOMP · Traditional | 12/20/2002SE |
| K021501 | V.A.C. Instillamat (Vacuum Assisted Closure InstillamatOMP · Traditional | 12/02/2002SE |
| K020781 | Wet ChamberNAD · Traditional | 05/06/2002SE |
| K992448 | V.A.C. PlusOMP · Traditional | 01/18/2000SE |
| K972176 | Home Care Bead BedINX · Traditional | 01/16/1998SE |
| K972549 | SimpulseFNM · Traditional | 11/18/1997SE |
| K955243 | BariairFNM · Traditional | 10/23/1997SE |
Questions and answers
When was V.A.C. Granufoam Silver Protection Dressing cleared by the FDA?
V.A.C. Granufoam Silver Protection Dressing (K050261) received a 510(k) decision of Substantially Equivalent on May 26, 2005, 111 days after the submission was received.
What is the product code of K050261?
The FDA product code is OMP – Negative Pressure Wound Therapy Powered Suction Pump, a Class II (moderate risk) device regulated under 21 CFR 878.4780.